Medtronic’s Enlite Sensor: The Waiting is the Hardest Part

When I was at the ADA Scientific Sessions in June, I had the chance to sit down with John Mastrototaro, Vice President of Research and Development for the diabetes business unit at Medtronic, and talk with him about some of Medtronic’s upcoming products and projects for people with diabetes. I was fascinated to hear what might be in the pipeline, but I also was curious to hear what it’s like to develop these systems — what the challenges and hurdles are, what the company’s hopes and goals might be, and what’s standing in the way. So it was a real treat to meet with John on the very same day that Minimed announced that it was applying for FDA approval for its 530G pump — the American version of the Veo, which has been out for several years in Europe.

I asked John to explain to me what made this new system special, and it turns out there are a couple exciting things. First, the new Enlite sensor — and I really should use “new” in quotation marks because it has been available in Europe for about a year — is much more comfortable and accurate than previous Minimed sensors. Second, the Veo pump itself has a glucose suspend feature, meaning that if the Enlite sensor detects your blood glucose is below 70, it can stop insulin delivery on its own. (Eventually this will be predictive.) I love this idea and personally think it’s a no-brainer — after all, you can override it if you’re conscious enough to disagree, and it only suspends glucose for a maximum of two hours. At its best, it saves your life. And at its worst, it contributes to a high for a couple hours. No harm, no foul, maybe an avoidance of a really nasty hypoglycemic episode. Sounds like a win to me.

Then, a few weeks ago, we got word of a new update in the Enlite/Veo story: that Medtronic had just won a 2012 International Design Excellence Award for their new Enlite Serter, pictured below. It’s the insertion device for their newest Continuous Glucose Monitoring system sensor, and works with the Paradigm Veo Insulin Pump. All three devices are a part of MiniMed’s 530G system, which – as noted above — the company submitted to the FDA in June of 2012 for regulatory approval.

Putting together some questions for their team left me with a bit of diabetes envy – why is this system already approved in 50 countries but not here?! – but I tried to view it as a chance to whet my appetite for what I hope I’ll eventually be able to try myself. (And if you want to read more about my conversation with John, check out the end of this earlier blog post). Here’s what Uli Rankers, Director, User Experience Design Engineering at Medtronic, had to say:

As you may know, the current Medtronic inserter is not looked on kindly by some of its users (I’ve heard it referred to as the “harpoon”). What makes the Enlite Serter different from Medtronic’s previous insertion system?

The Sen-serter (what is currently approved for use with Sof-sensor) has:

A 45° angle placement

A Serter with exposed mechanism

A needle that is visible throughout the process; and

A bare needle to remove and dispose of

The design challenge with the Enlite Serter was to make a process involving multiple parts, steps, and a needle as easy and unthreatening as possible.

The strategies we used to try to meet this challenge included:

Minimizing the visibility of the needle

Reducing the diameter of the needle

Using a 90-degree angle placement

Creating a softer form factor that can be triggered by either the finger or the thumb.

Using a material called elastomer (a soft material) to reduce the noise of the mechanism

Reducing the time to perform the process

The Enlite Serter sounds like a great improvement over current technology — but I assume that you and your team are already thinking ahead. Can you give us a hint of what you hope the future of insertion sets might be like? What is the ultimate goal?

Unfortunately, I can’t talk about future products. But I can tell you we’ll continue to work to design products that are simpler and easier to use for our customer while continuing to maintain our commitment to safety and quality.

We have to ask: like the Enlite sensor itself, the Enlite Serter is not yet available in the U.S. market. So where is it currently available? And — while I know you can’t make specific predictions — what phase/stage is it in here? What hurdles still have to be overcome before it’ll be available in the US market?

This Enlite Serter is currently not approved for sale in the U.S. However, it is available in 50 countries outside the U.S. We can’t predict regulatory timelines, but I can tell you that the Enlite Serter is part of the MiniMed 530 system we submitted to the FDA in June of this year.

What do you wish that the people who use your products understood about the design of diabetes devices and supplies?

More and more focus is being placed on the front-end development of our devices, understanding the customer needs through voice of customer surveys and other research and by applying an iterative concept development cycle that includes verification/formative Human Factors studies. We do hear you when you say you want more current, consumer-friendly devices and we’re working to develop those types of products. At the same time, these are medical devices and, therefore, the safety and quality must always be (and will always be) top priority for us.

Lastly, what kind of patient feedback would be useful for you to hear — and what’s the best way to pass it along?

We often conduct surveys and focus groups among people living with diabetes. So, participation in that type of market research when you get the opportunity is very helpful to us. In addition, we launched a blog (www.loop-blog.com) about a year and a half ago, followed by Twitter (@MDT_Diabetes) and, most recently, a Facebook page. It’s always great to hear feedback from the diabetes community through those channels as well.

Comments (4)

I broke my Medtronic Guardian RealTime CGM and I’m waiting for US FDA approval of the Enlite… But I just found this link http://seekingalpha.com/article/820251-medtronic-management-discusses-q1-2013-results-earnings-call-transcript from a Medtronic stockholder meeting that says they don’t expect approval until late financial year 2013 (which ends Sept 2013). That sucks! I want to go back on CGM sooner than that!!!!